A Pharmacokinetic Study of Risperidone and Topiramate Administered Alone and in Combination in Patients With Bipolar Disorder or Schizoaffective Disorders

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the potential pharmacokinetic (absorption, distribution and excretion of the drug by the body) interaction between, and the safety of, topiramate and risperidone administered in combination in patients with a history of either bipolar spectrum or schizoaffective (bipolar type) disorders as defined by DSM-IV criteria.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone; Topiramate

Criteria

Inclusion Criteria:

• Patients meeting DSM-IV criteria for either Bipolar I Disorder, Bipolar II Disorder, Cyclothymic Disorder, Bipolar Disorder NOS, or Schizoaffective Disorder (bipolar type)

• Patients not in the midst of an acute manic, major depressive, or schizoaffective episode and had not experienced an acute episode within the month prior to screening

• Women were to be postmenopausal for at least 1 year, or surgically incapable of childbearing, or practicing an acceptable method of birth control (hormonal contraception, intrauterine device, or barrier with spermicide were acceptable) and not pregnant at baseline.

Exclusion Criteria:

• Patients with a history of an acquired or hereditary neurologic disease, e.g., epilepsy or significant brain trauma

• Patients using prescription medication, including psychotropic medications, within 14 days prior to the first day of Period I with the exception of hormonal contraceptives (women), risperidone, or other medications approved by the sponsor

• Patients on depot medications (including but not limited to haloperidol decanoate)

• Patients who had taken acetazolamide, zonisamide, triamterene, dichlorphenamide, chronic antacids, or calcium supplements, or any medication associated with nephrolithiasis in the month prior to beginning TPM titration.